Federal Circuit: Plans for Future Activity Created a Substantial Risk of Future Infringement

By Ryan Camp and Tom Ritchie –

Restem, LLC v. Jadi Cell, LLC (Fed. Cir. Mar. 4, 2025) (Moore, Schall, and Taranto) (on appeal from Patent Trial and Appeal Board) [INHERENT ANTICIPATION, CLAIM CONSTRUCTION, STANDING]

Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression profile.  The Board held all challenged claims were not shown to be unpatentable.  Restem appealed.  The Federal Circuit found Restem had Article III standing, despite no litigation in the U.S., because Restem’s plans for future activity created a substantial risk of future infringement.  The Federal Circuit subsequently affirmed the Board’s (i) constructions of the “placing” step and “an isolated cell” term; and (ii) findings that the prior art did not inherently anticipate—or render obvious for the same reasons—the ’176 Patent.

The Federal Circuit first found that the Board did not construe the “placing” claim language to require steps beyond their stated construction and any additional steps noted in the Board’s opinion were in support of its validity analysis.  The Federal Circuit also agreed with the Board’s implicit construction of “an isolated cell,” noting the applicant narrowed the claim scope to “a cell population” when they acquiesced to the Examiner’s statements regarding the same.

The Federal Circuit then addressed the Board’s finding that the ’176 Patent was not inherently anticipated.  Restem argued that once the process steps were met, the product was necessarily present.  The Federal Circuit disagreed, finding that substantial evidence supported the Board’s finding that, despite satisfying the process steps, the prior art process cells “would not necessarily have the claimed cell marker expression profile.”  The Federal Circuit explained that Restem “conflate[d] the anticipation and infringement analyses for product-by-process claims by improperly shifting the analysis from whether the prior art discloses the claimed product to whether the prior art discloses the claimed process.”  Accordingly, the Federal Circuit affirmed the Board’s findings.